Tags: Coronavirus | Coronavirus Special | Health Topics | Trump Administration | Vaccines | fda | white house

FDA Official: White House Could Block Guidance on Vaccine

Female doctor with a stethoscope on shoulder holding syringe and COVID-19 vaccine
(Siam Pukkato/Dreamstime)

By    |   Monday, 28 September 2020 06:03 PM

A top official at the Food and Drug Administration said Monday the White House could prevent the agency from releasing stricter guidelines for a coronavirus vaccine, Politico reports.

Phillip Krause, the deputy director of the Center for Biologics Evaluation and Research at the FDA, told the World Vaccine Congress on Monday the agency is committed to making sure vaccine makers complete full clinical trials for any shot that gets emergency authorization.

"It's a point of significant importance to make sure that the companies understand what's needed for an emergency authorization," Krause said. "The key point is an EUA vaccine is still investigational — clinical trials will continue and more safety data will be collected."

President Donald Trump has repeatedly insisted a coronavirus vaccine will be made available by Election Day, but top federal health officials have stressed it is unlikely a vaccine will be ready by then.

"The earlier a [vaccine] developer chooses to look at their data, and there are statistical rules for when and how to they can do this, the less likely it is they'll have accumulated the full complement of data that we would like to see in order to make a decision to deploy a vaccine in a more widespread way," Krause said.

Politico notes two top executives at major pharmaceutical companies, including Johnson & Johnson chief scientific officer Paul Stoffels and Merck executive vice president Julie Gerberding, have both come out in favor of the FDA releasing vaccine guidelines to the public.

"Transparency really matters right now," Gerberding said. "Even if the guidance isn't shocking, we need to err on the side of transparency."

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A top official at the Food and Drug Administration said Monday the White House could prevent the agency from releasing stricter guidelines for a coronavirus vaccine, Politico reports.
fda, white house, guidelines, clinic, testing, trials
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2020-03-28
Monday, 28 September 2020 06:03 PM
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